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Sponsored by: |
National Institute of Mental Health (NIMH) |
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00183274 |
This study will assess the effectiveness of venlafaxine XR in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.
Condition | Intervention | Phase |
Anxiety Disorders |
Drug: Venlafaxine XR Drug: Placebo |
Phase IV |
MedlinePlus related topics: | Anxiety |
Drug Information available for: | Venlafaxine Venlafaxine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Short-Term Versus Long-Term Treatment in Generalized Anxiety Disorder |
Estimated Enrollment: | 330 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Venlafaxine
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Drug: Venlafaxine XR
All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine.
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2: Experimental
Venlafaxine and placebo
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Drug: Venlafaxine XR
All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine.
Drug: Placebo
After initial treatment with venlafaxine, some participants will be randomized to take placebo for 6 months in the second phase of the study and then to switch back to venlafaxine or continue with placebo for an additional 6 months.
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Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD are unable to relax and often suffer from insomnia. Venlafaxine XR, a drug used to treat depression, has been shown to be effective in the short-term treatment of GAD. However, its benefits over a course of more than 8 weeks have not been assessed. This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment.
Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR. Upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo. After 12 months, participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo. Participants will have 22 study visits over at least 18 months. Follow-up visits will occur 24 months after enrollment. Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale. A variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karl Rickels, MD | 215-746-6417 | krickels@mail.med.upenn.edu |
United States, Pennsylvania | |||||
University of Pennsylvania, 3535 Market Street, Suite 670 | Recruiting | ||||
Philadelphia, Pennsylvania, United States, 19104-3309 | |||||
Contact: Karl Rickels, MD 215-746-6417 krickels@mail.med.upenn.edu | |||||
Contact: Bijan Etemad, MD 215-898-4301 betemad@mail.med.upenn.edu |
Principal Investigator: | Karl Rickels, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Karl Rickels, MD ) |
Study ID Numbers: | R01 MH65963, DSIR 83-ATAS |
First Received: | September 12, 2005 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00183274 |
Health Authority: | United States: Federal Government |
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